Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV

NCT04161235 | Completed FDA Device

• 1 other identifier: 630-0025-01
• Study Type: observational
• Target: 2
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• Treated Lobar Volume Reduction (TLVR) responders

  The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days.

  45 days

Other Outcomes (8)

• Treated Lobar Volume Reduction (TLVR) changes from Baseline

  45 days

• Lobar occlusion

  45 days

• Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)

  3 months

Study Arms (1)

Treatment

Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP

Interventions

The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP DEVICE

The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.

You may qualify if:

• Patients with severe emphysema prescribed treatment with Zephyr Valves
• Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV

You may not qualify if:

• Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
• Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (3)

Ruhrlandklinik Essen - Universitätsmedizin

Essen, 45239, Germany

Location

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Emphysema

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: February 5, 2020
• Primary Completion: August 13, 2021
• Study Completion: December 30, 2021
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (1); CH (1)